dosage and administration1

In elderly patients or patients unable to tolerate MARINOL 2.5 mg twice daily, the dosage can be reduced to 2.5 mg/day, administered as a single dose one hour before dinner or at bedtine to reduce the risk of CNS symptoms..

Most patients respond to MARINOL 2.5 mg twice daily. The dose may be further increased to 5 mg one hour before lunch and 5 mg one hour before dinner as tolerated to achieve therapeutic effect.

Clinical Trials Dosing

Appetite Stimulation in AIDS-Related Anorexia With Weight Loss:

The pharmacologic effects of MARINOL are dose-related and subject to considerable interpatient variability. Therefore, dosage individualization is critical in achieving the maximum benefit of MARINOL treatment.

In the clinical trials, the majority of patients were treated with 5 mg/day MARINOL, although the dosages ranged from 2.5 to 20 mg/day.

For an adult:

Begin with 2.5 mg one hour before lunch and 2.5 mg one hour before dinner. If CNS adverse reactions (feeling high, dizziness, confusion, somnolence) do occur, they usually resolve in 1 to 3 days with continued dosage.

If CNS adverse reactions are severe or persistent, reduce the dose to 2.5 mg in the evening or at bedtime.

Dosing later in the day may reduce the frequency of CNS adverse reactions. CNS adverse reactions are dose-related; therefore monitor patients and reduce the dosage as needed.

When adverse effects are absent or minimal and further therapeutic effect is desired, increase the dose to 2.5 mg one hour before lunch and 5 mg one hour before dinner.

The maximum dosage is 10 mg twice daily.

Indication and important safety information

INDICATION1

MARINOL® (dronabinol) is a cannabinoid indicated in adults for the treatment of:

Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

MARINOL is contraindicated in patients with a known history of a hypersensitivity reaction to dronabinol or sesame oil. Reported hypersensitivity reactions to dronabinol capsules include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, and throat tightness.

WARNINGS AND PRECAUTIONS

Neuropsychiatric Adverse Reactions

Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Avoid use in patients with a psychiatric history, or if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment. Avoid concomitant use with other drugs with similar psychiatric effects.

Reduce the dose or discontinue MARINOL if signs or symptoms of cognitive impairment or altered mental state occur. Use with caution in elderly patients who may be more sensitive to the neurological and psychoactive effects of MARINOL.

Inform patients not to drive or operate machinery until it is reasonably certain that MARINOL does not affect them adversely. Avoid concomitant use of sedatives, hypnotics, or other psychoactive drugs because of the potential for additive CNS effects.

Hemodynamic Instability

Monitor patients for changes in blood pressure, heart rate, and syncope, as patients (especially the elderly or those with cardiac disorders) may experience or be at increased risk of these hemodynamic changes after initiation or increasing the dosage of MARINOL.

Avoid concomitant use of drugs associated with similar cardiac effects.

Seizures

Weigh the risks vs benefits of prescribing MARINOL in patients with a history of seizures, including those requiring anti-epileptic medications or with other factors that lower the seizure threshold.

Monitor patients with a history of seizure disorders for worsened seizure control, and discontinue MARINOL if seizures occur.

Multiple Substance Abuse

Assess risk for abuse or misuse prior to prescribing MARINOL in patients with a history of substance abuse or dependence (including alcohol or marijuana).

Monitor patients for the development of these behaviors or conditions.

Paradoxical Nausea, Vomiting, or Abdominal Pain

Monitor patients and ask caregivers about the development of worsening nausea, vomiting, or abdominal pain during MARINOL treatment.

Consider dose reduction or discontinuation in patients who develop worsening symptoms while on treatment.

Indication and important safety information

Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

MARINOL is contraindicated in patients with a known history of a hypersensitivity reaction to dronabinol or sesame oil. Reported hypersensitivity reactions to dronabinol capsules include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, and throat tightness.

WARNINGS AND PRECAUTIONS

Neuropsychiatric Adverse Reactions

Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Avoid use in patients with a psychiatric history, or if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment. Avoid concomitant use with other drugs with similar psychiatric effects.

Reduce the dose or discontinue MARINOL if signs or symptoms of cognitive impairment or altered mental state occur. Use with caution in elderly patients who may be more sensitive to the neurological and psychoactive effects of MARINOL.

Inform patients not to drive or operate machinery until it is reasonably certain that MARINOL does not affect them adversely. Avoid concomitant use of sedatives, hypnotics, or other psychoactive drugs because of the potential for additive CNS effects.

Hemodynamic Instability

Monitor patients for changes in blood pressure, heart rate, and syncope, as patients (especially the elderly or those with cardiac disorders) may experience or be at increased risk of these hemodynamic changes after initiation or increasing the dosage of MARINOL.

Avoid concomitant use of drugs associated with similar cardiac effects.

Seizures

Weigh the risks vs benefits of prescribing MARINOL in patients with a history of seizures, including those requiring anti-epileptic medications or with other factors that lower the seizure threshold.

Monitor patients with a history of seizure disorders for worsened seizure control, and discontinue MARINOL if seizures occur.

Multiple Substance Abuse

Assess risk for abuse or misuse prior to prescribing MARINOL in patients with a history of substance abuse or dependence (including alcohol or marijuana).

Monitor patients for the development of these behaviors or conditions.

Paradoxical Nausea, Vomiting, or Abdominal Pain

Monitor patients and ask caregivers about the development of worsening nausea, vomiting, or abdominal pain during MARINOL treatment.

Consider dose reduction or discontinuation in patients who develop worsening symptoms while on treatment.

SAFETY CONSIDERATIONS1

MARINOL is contraindicated in patients with a history of hypersensitivity to dronabinol or sesame oil. MARINOL may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Avoid use in patients with a psychiatric history. Monitor for symptoms and avoid concomitant use of drugs with similar psychiatric effects. Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that MARINOL does not affect them adversely. Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Avoid concomitant use of drugs with similar cardiac effects. Weigh potential risk vs benefit of MARINOL in patients with history of seizures, and discontinue if seizures occur. Assess risk for abuse or misuse in patients with history of substance abuse or dependence before prescribing MARINOL. Consider MARINOL dose reduction or discontinuation if worsening of paradoxical nausea, vomiting, or abdominal pain occurs while on treatment.

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